Those opposed to pharming fear that through either mishandling or gene flow, potentially dangerous pharmaceuticals may inadvertently enter the food supply. Precedents involving non-pharmaceutical genetically modified crops include the Starlink controversy, and trade war over genetically modified food between the European union and the USA. A similar reaction to pharmed rice is feared from Japan. Expression in the milk of a genetically-modified goat was ATryn, but marketing permission was blocked by the European Medicines Agency in February 2006.[2] This decision was reversed in June 2006 and approval was given August 2006.[3] Within the United States, Transgenic plants including but not limited to those which produce pharmaceuticals, are regulated by three government agencies which comprise the Coordinated Framework for Regulation of Biotechnology established in 1986. Compared to conventional production methods, but there are also considerable regulatory challenges that must be met. There are currently about 30 protein-based medicines on the market, and close to 100 in late-stage human trials. Consequently, companies are motivated to provide a wider range of options for production of proteins used in these treatments. One approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk (or blood or urine). Once an animal is produced, typically using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome.[1] The first such drug manufactured from the milk of a mammal, such.